Patenting human genes: A Q&A on Myriad Genetics

Jordan Paradise, associate professor of law at Seton Hall Law School and specialist in genetics and nanotechnology.

Should a profit-making company be able to patent genes and genetic material extracted from our bodies? It has happened: The U.S. Patent and Trademark Office has issued thousands of such patents the past 30 years, a trend that has accelerated since the initial sequencing of the human genome in 2001.

The U.S. Supreme Court is expected to weigh in as early as today on the case of Association of Molecular Pathology vs. Myriad Genetics. Myriad has laid claim to mutations in the genes that signal a predisposition to breast and ovarian cancer — BRCA1 and BRCA2 — and is the only company that can do research on the mutation and administer the test that reveals its presence in the body.

The tests, famously used by actress Angelina Jolie in her decision to undergo a double mastectomy, are costly — about $3,000 — and some say the patents also limit access to the information, preventing other researchers from using the material for further innovations that could lead to cheaper testing and even a cure.

Star-Ledger editorial writer Linda Ocasio spoke with Jordan Paradise, associate professor of law at Seton Hall Law School, and a specialist in genetics and nanotechnology, about the Myriad case.

Why is the U.S. Supreme Court examining Myriad Genetics?

The case asks a single question: Are human genetic materials patent-eligible subject matter under U.S. patent law? Patents can be issued for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”

Once issued, a patent creates a legal monopoly for the patent holder, extending for 20 years from the date of the filing of the patent application. Laws of nature, natural phenomenon and abstract ideas are not patentable. This exception has been cited in Supreme Court cases dating back to the 1800s.

In the last couple of years, the Supreme Court has become increasingly skeptical of the decisions in the federal circuit court, which has created its own series of tests to assess whether an invention is eligible to be patented. In several recent cases, the court has limited the applicability of these tests and called into question the scope of particular patent claims issued by the patent office.

It’s an important issue. We’re essentially asking whether you can take something out of nature and say you invented it and that it’s now your property. The implications of these patent claims tie into cost, access and personhood. Myriad said they have transformed the genetic material sufficiently to create something new.

Everything rests on whether a transformation occurred?

Yes. This idea of transformation is linked to the question of whether isolating DNA from its natural environment is enough to rise to the level of invention. At what level is it transformed and is thus no longer a product of nature?

Myriad Genetics here claimed the DNA sequence information itself, which has become highly controversial. The patent office position, upheld by the federal circuit, is that isolation and purification of genetic sequences make them patent-eligible. Exactly what isolation and purification means is unclear, and the trend has been for patent applicants to include those key terms in their patent claims without elaborating on the practical meaning.

Myriad Genetics has also strenuously enforced their patents through cease-and-desist letters to other researchers, and has used patient tissue samples to develop a proprietary DNA database for future research and commercialization. Scientists have been denied access to the genetic information for research and publications. Patients can’t go to their own doctors for the test, and genetic counselors can’t advise their patients about their options. Individuals must send a sample of their DNA to Myriad, which then collects the data.

I’m on the side of access, not keeping genetic information proprietary. Access would increase robust research by others, increase access to patients, and reduce the costs of diagnostic tests. A diagnostic kit to detect a specific genetic mutation may rise to the level of an invention and acquire patent protection, but the underlying genetic information does not.

What about people who say the profit factor alone motivates innovation?

I’ve never been convinced by that argument. Go back to the literature, and what fueled the Human Genome Project in the first place: the scientific endeavor, the pursuit of knowledge. The information should be publicly available to support future innovation.
One historic example of the limits of patent law is the telegraph. In the 1854 case of O’Reilly v. Morse, the Supreme Court told Samuel Morse that he could not patent electromagnetism itself, only the invention of the telegraph, which utilized that basic scientific fact. Morse didn’t invent electromagnetism, and Myriad Genetics didn’t invent the genetic sequence.